Eyes on New Product Development

Abstract

In this recent period, the U.S. FDA approved a new fixed dose combination ocular hypotensive agent, a formulation of an ophthalmic nonsteroidal anti-inflammatory agent, and an unapproved topical vasoconstrictor, two agents to treat retinal disease were launched in Europe, and several firms made development progress in novel ophthalmic pharmaceuticals. As well, a novel dry eye therapy being developed by a startup firm was acquired by a major pharmaceutical firm.

Ophthalmic Pharmaceuticals

• Alcon announced U.S. FDA approval of Simbrinza™ Suspension, a fixed-combination of brinzolamide 1% and brimonidine tartrate 0.2% for the treatment of elevated intraocular pressure in patients with glaucoma and ocular hypertension (April 2013).

• Alimera Sciences announced that ILUVIEN^® (fluocinolone acetonide implant) is now available in the United Kingdom (April 2013).

• Bausch+Lomb announced that the U.S. FDA approved Prolensa™ (bromfenac ophthalmic solution) 0.07% for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery (April 2013).

• EyeGate Pharma has completed a Phase 3 study of EGP-437, a corticosteroid formulation delivered by iontophoresis, for treatment of anterior uveitis (April 2013).

• Genable Technologies' gene therapy product, GT038, has been granted Orphan Drug Designation by the FDA for the treatment of retinitis pigmentosa (April 2013).

• GenSight Biologics is receiving funding to develop gene replacement therapies for a pair of orphan targets: Leber's hereditary optic neuropathy (LHON) and retinitis pigmentosa (April 2013).

• MorphoSys AG received a milestone payment from Novartis in connection with the clinical trial application and projected initiation of a Phase 1 clinical trial. The HuCAL-derived, fully human antibody will be developed in the therapeutic area of ophthalmology (May 2013).

• NovaBay Pharmaceuticals has enrolled the first patients in Brazil into its global Phase 2b clinical trial, BAYnovation. The trial is investigating auriclosene (NVC-422) Ophthalmic Solution as a treatment for adenoviral conjunctivitis (April 2013).

• Novaliq GmbH, announced successful completion of a round of financing to aid in development of an ophthalmic product pipeline for drug delivery of poorly soluble drugs, including treatments for dry eye (April 2013).

• Omeros Corporation announced that the European Medicines Agency (EMA) has confirmed that the Company's planned Marketing Authorization Application (MAA) for its ophthalmology product OMS302 (a combination of mydriatic and anti-inflammatory agents), may be submitted and reviewed under the EMA's centralized procedure (April 2013).

• Paragon BioTeck received FDA approval for phenylephrine hydrochloride ophthalmic solution, USP 2.5% and 10% to dilate the pupil. The product has now been licensed to Bausch+Lomb (April 2013).

• QLT, Inc. announced it has completed the sale of the Company's punctal plug drug delivery system (“PPDS”) technology to Mati Therapeutics, Inc. (April 2013)

• Shire will buy SARcode Bioscience to gain rights to lifitegrast, currently in Phase 3 development for the treatment of dry eye (March 2013).

• ThromboGenics' JETREA^® (ocriplasmin) was launched in the United Kingdom and Germany (April 2013).

Regulatory, Government, and Pharmaceutical Industry

• FDA did not approve abbreviated new drug applications for generic oxycodone (OxyContin^®) immediate-release formulations based upon their abuse potential. Purdue Pharma, the innovator, had introduced a sustained release product, OxyContin-SR^®, in 2010, which has protections against abuse (April 2013).

• New Jersey passed a law that would ensure continuity of therapy for patients with eye and sight problems. This legislation will allow for the uninterrupted administration of necessary eye medication for patients who are in need of early refills, consistent with selected other states (May 2013).

• Potiga (Ezogabine), an antiseizure medication has been linked to blue skin discoloration and eye abnormalities characterized by pigment changes in the retina (April 2013).

Footnotes

Author Disclosure Statement

The author consults for numerous ophthalmic pharmaceutical and medical device firms.